SILVER SPRING, Md. – The US Food and Drug Administration on Jan. 4 prohibited certain uses of the cephalosporin class of antimicrobial drugs in cattle, swine, chickens and turkeys effective April 5.
FDA is prohibiting extra-label, or unapproved, uses of cephalosporins in cattle, swine, chickens and turkeys. Specifically, the prohibited uses include:
- using cephalosporin drugs at unapproved dose levels, frequencies, durations, or routes of administration;
- using cephalosporin drugs in cattle, swine, chickens or turkeys that are not approved for use in that species (e.g., cephalosporin drugs intended for humans or companion animals); and
- using cephalosporin drugs for disease prevention.
"We believe this is an imperative step in preserving the effectiveness of this class of important antimicrobials that takes into account the need to protect the health of both humans and animals," said Michael R. Taylor, Deputy Commissioner for Foods.
Cephalosporins are commonly used in humans to treat pneumonia and skin and soft tissue infections. They also are used to treat pelvic inflammatory disease, diabetic foot infections, and urinary tract infections, according to FDA.
Reaction to the new rule was mixed between public interest groups praising the action and industry urging caution about restricting antibiotic use. Antibiotics are an important tool to ensuring animal health and wholesome food, said Tom Super, National Chicken Council vice president of communications.
“Antibiotics are used sparingly in chicken production, and only if they are approved by the FDA," Super said. "A majority of the antibiotics, such as Ceftiofur, are not used in human medicine meaning the threat of creating resistance is essentially reduced to zero."
He expressed concern that the rule on extra-label drug use would take medical decisions to treat animals away from veterinarians.
"We question any substantive link or scientific basis between veterinary use of cephalosporins and antibiotic resistance in humans,” he said.
The Pew Charitable Trusts called the FDA action "a good first step."
"We applaud FDA's move," said Laura Rogers, project director of the Pew Campaign on Human Health and Industrial Farming. "This restriction is a victory for human health, as it will help ensure we can still rely on cephalosporins to treat life-threatening infections today and in the future."
The order is not a blanket prohibition. It does not limit the use of cephapirin, an older cephalosporin drug that is not believed by FDA to contribute significantly to antimicrobial resistance.
Also, veterinarians can still use or prescribe cephalosporins for limited extra-label use in cattle, swine, chickens or turkeys as long as they follow the dose, frequency, duration, and route of administration that is on the label, FDA said. Veterinarians may also use or prescribe cephalosporins for extra-label uses in minor species used for food such as ducks or rabbits.